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Pharmacovigilance

Role of AI in Literature Monitoring in Pharmacovigilance

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and […]

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Barriers medical device adverse event reporting

Identifying Barriers in Reporting Medical Device Adverse Effects

Blogs, Pharmacovigilance, Regulatory /

Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for

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Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims

Blogs, Pharmacovigilance, Regulatory /

As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential

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FDA Update REMS Public Dashboard

FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access

Blogs, Pharmacovigilance, Regulatory /

The U.S. Food and Drug Administration has launched the REMS (Risk Evaluation and Mitigation Strategy) Public Dashboard to enhance access to data related to REMS programs using an interactive, secure, and web-based tool. Such a dashboard will help streamline user-friendly access for health care providers, research organizations, academia, industry professionals, and the general public to

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Declaration of Helsinki 2024

Updates to the Declaration of Helsinki

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants

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Emerging Drug Safety Technology Program

Blogs, Pharmacovigilance /

Pharmacovigilance practices are associated with several challenges related to collection of safety data, processing, assessment, and volume of patient safety data. As technological disruptors- like artificial intelligence (AI)- develop, so do the solutions to tackle such challenges. This leads to more efficient pharmacovigilance (PV) systems and processes that ultimately enhance drug safety monitoring. Whether it

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REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory /

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents

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The Impact of Interactive Safety Graphics in Clinical Settings

Blogs, Clinical Regulatory, Pharmacovigilance /

The world of regulatory submissions is transforming where static documents and data tables are slowly giving way to a more dynamic approach – interactive safety graphics. Traditional methods of presenting this data have evolved significantly with the advent of interactive safety graphics. These dynamic tools are transforming the way submission content is reviewed, how clinical study reports

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Leveraging Statistical Approaches in Drug Safety Analysis

Blogs, Clinical Regulatory, Pharmacovigilance /

Drug safety in clinical trials is ensured through the application of statistical approaches. Adequate planning for safety analyses helps in identifying potential adverse events, evaluating their impact and ensuring that the benefits of a drug are greater than the risks associated with it. It starts from early stages i.e., with the designing of clinical trials

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Pharmacovigilance in New Zealand

Blogs, Pharmacovigilance /

Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides

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